Children after open-heart surgery for congenital cardiac disease MedDRA version: 9.1 Level: LLT Classification code 10019273 Term: Heart disease congenital
Conditions
Interventions
Trade Name: HyperHAES®
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Poly(O-2-hydroxyethyl)starch
Other descriptive name: Poly(O-2-hydroxyethyl)starch
Concentration unit: g/l gram(s)
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent of the legal guardian and consent of the patient, if applicable • Age: 1 month to 5 years • Patients with up to now untreated cyanotic or acyanotic organic heart defects, after open-heart surgery with cardio-pulmonal-bypass • Body weight: > 3,5 kg up to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Age > 5 years • Body weight 50 kg • Known hypersensitivity against hydroxyethyl starch in the patient's history • Evidence in the patient's history of hemorrhagic diathesis • Pre-surgical manifest heart insufficiency (NYHA-classification: degree IV) • Thrombopenia (Thr 150 mmol/l • Pre-surgical hyperchloremia • Calculated serum osmolarity: > 350 mosm/l • Acute life threatening hypovolemic shock • Dehydration • Hyperhydration • Oliguria/Anuria • Known disturbance of haemostasis • Contraindications in the product information (SmPC) of HyperHAES® or Isotonische Kochsalzlösung Fresenius® do apply • participation in another clinical trial with an investigational medicinal product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate whether hypertonic-hyperoncotic solutions infusions in toddlers and children aged up to 5 years after open-heart surgery for congenital cardiac disease improve the cardiac index within 20 hours after application in comparison to placebo (isotonic saline solution) ;Secondary Objective: 1) to determine whether the administration of hypertonic-hyperoncotic solutions could influence in comparison to placebo (isotonic saline solution) within the first 20 h after application: • the need of volume replacement • the need of catecholamins • the frequency of a capillary leakage syndrome • the serum level of ANF • the second messenger cyclic Guanosin-3',5´-monophosphat (cGMP) • secondarily effects the cortisol-cortisone converting enzyme 11-ß-HSD • diuresis • the need of diuretics. 2) to investigate wether the administration of hypertonic-hyperoncotic solutions is a safe therapy in this patient collective;Primary end point(s): Cardiac index: at baseline (0 minutes), 15 minutes, 1 hour, 4 hours, 12 hours and 20 hours after application of the study solution (HyperHAES® or Isotonische Kochsalzlösung Fresenius®). The cardiac index will be compared at the different time points to the baseline value, in the time course and between the 2 treatment arms (verums vs. placebo). | — |
Countries
Germany
Outcome results
None listed